Friedreich Ataxia ' Pipeline Review, H2 2012

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Friedreich Ataxia ' Pipeline Review, H2 2012
Published on October 2012

Report Summary


Summary

Global Markets Direct's, 'Friedreich Ataxia - Pipeline Review, H2 2012', provides an overview of the indication's therapeutic pipeline.
This report provides information on the therapeutic development for Friedreich Ataxia, complete with latest updates, and special
features on late-stage and discontinued projects. It also reviews key players involved in the therapeutic development for Friedreich
Ataxia. Friedreich Ataxia - Pipeline Review, Half Year is built using data and information sourced from Global Markets Direct's
proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from
company/university sites and industry-specific third party sources, put together by Global Markets Direct's team.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated
disease.

Scope

- A snapshot of the global therapeutic scenario for Friedreich Ataxia.
- A review of the Friedreich Ataxia products under development by companies and universities/research institutes based on
information derived from company and industry-specific sources.
- Coverage of products based on various stages of development ranging from discovery till registration stages.
- A feature on pipeline projects on the basis of monotherapy and combined therapeutics.
- Coverage of the Friedreich Ataxia pipeline on the basis of route of administration and molecule type.
- Key discontinued pipeline projects.
- Latest news and deals relating to the products.

Reasons to buy

- Identify and understand important and diverse types of therapeutics under development for Friedreich Ataxia.
- Identify emerging players with potentially strong product portfolio and design effective counter-strategies to gain competitive
advantage.
- Plan mergers and acquisitions effectively by identifying players of the most promising pipeline.
- Devise corrective measures for pipeline projects by understanding Friedreich Ataxia pipeline depth and focus of Indication
therapeutics.
- Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to
enhance and expand business potential and scope.
- Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline.

Friedreich Ataxia ' Pipeline Review, H2 2012 (From Slideshare) Page 1/6


Table of Content

Table of Contents
Table of Contents 2
List of Tables 4
List of Figures 5
Introduction 6
Global Markets Direct Report Coverage 6
Friedreich Ataxia Overview 7
Therapeutics Development 8
An Overview of Pipeline Products for Friedreich Ataxia 8
Friedreich Ataxia Therapeutics under Development by Companies 10
Friedreich Ataxia Therapeutics under Investigation by Universities/Institutes 11
Late Stage Products 12
Comparative Analysis 12
Mid Clinical Stage Products 13
Early Clinical Stage Products 14
Pre-Clinical Stage Products 15
Friedreich Ataxia Therapeutics ' Products under Development by Companies 16
Friedreich Ataxia Therapeutics ' Products under Investigation by Universities/Institutes 17
Companies Involved in Friedreich Ataxia Therapeutics Development 18
ViroPharma Incorporated 18
Repligen Corporation 19
Santhera Pharmaceuticals Holding AG 20
Varinel, Inc. 21
STATegics, Inc. 22
Friedreich Ataxia ' Therapeutics Assessment 23
Assessment by Monotherapy Products 23
Assessment by Route of Administration 24
Assessment by Molecule Type 26
Drug Profiles 28
Indole-3-Propionic Acid - Drug Profile 28
Product Description 28
Mechanism of Action 28
R&D Progress 28
VAR-10300 - Drug Profile 30
R&D Progress 30
VAR-10100 - Drug Profile 32
R&D Progress 32



epoetin alfa - Drug Profile 33
R&D Progress 33
idebenone - Drug Profile 34
R&D Progress 34
RG-2833 - Drug Profile 36
R&D Progress 36
pioglitazone hydrochloride - Drug Profile 38
R&D Progress 38
Resveratrol - Drug Profile 39
R&D Progress 39
STS-E15 - Drug Profile 40
R&D Progress 40
Friedreich Ataxia Therapeutics ' Drug Profile Updates 41
Friedreich Ataxia Therapeutics ' Discontinued Products 44
Friedreich Ataxia Therapeutics - Dormant Products 45
Friedreich Ataxia ' Product Development Milestones 46
Featured News & Press Releases 46
Mar 15, 2012: Repligen Initiates Phase I Clinical Trial Of RG2833 In Patients With Friedreich's Ataxia 46
Apr 12, 2011: Intellect Neurosciences Files Orphan Drug Application In US For OX1 In Friedreich's Ataxia 47
May 24, 2010: Repligen Receives FDA Orphan Drug Designation For RG2833 For Treatment Of Friedreich's Ataxia 47
May 20, 2010: Santhera's MICONOS Trial With Catena/Sovrima in Friedreich's Ataxia Misses Primary Endpoint 48
May 13, 2010: Repligen Files Investigational New Drug Application with FDA for First Drug Targeting The Core Genetic Defect Of
Friedreich's Ataxia 49
Feb 17, 2010: Otonomy Wins FDA Clearance To Initiate Clinical Trial Of OTO-104 Against Menieres Disease 50
Jan 11, 2010: Penwest Pharmaceutical Announces Initiation Of Phase IIa Clinical Trial of A0001 In Patients With Friedreich's Ataxia
50
Nov 02, 2009: Lundbeck Starts Clinical Phase IIa With Lu AA24493 (cEPO) In Friedreich's Ataxia In A Study Also Assessing Efficacy
Via Biomarkers 51
May 26, 2009: New Study To Examine Whether Smoking Cessation Drug Varenicline (Chantix) May Benefit Adults With Friedreich'S
Ataxia 52
May 19, 2009: Santhera's US Phase III IONIA Trial In Friedreich's Ataxia Misses Primary Endpoint 52
Appendix 54
Methodology 54
Coverage 54
Secondary Research 54
Primary Research 54



Expert Panel Validation 54
Contact Us 55
Disclaimer 55

List of Tables

Number of Products Under Development for Friedreich Ataxia, H2 2012 8
Products under Development for Friedreich Ataxia ' Comparative Analysis, H2 2012 9
Number of Products under Development by Companies, H2 2012 10
Number of Products under Investigation by Universities/Institutes, H2 2012 11
Comparative Analysis by Late Stage Development, H2 2012 12
Comparative Analysis by Mid Clinical Stage Development, H2 2012 13
Comparative Analysis by Early Clinical Stage Development, H2 2012 14
Comparative Analysis by Pre-Clinical Stage Development, H2 2012 15
Products under Development by Companies, H2 2012 16
Products under Investigation by Universities/Institutes, H2 2012 17
ViroPharma Incorporated, H2 2012 18
Repligen Corporation, H2 2012 19
Santhera Pharmaceuticals Holding AG, H2 2012 20
Varinel, Inc., H2 2012 21
STATegics, Inc., H2 2012 22
Assessment by Monotherapy Products, H2 2012 23
Assessment by Stage and Route of Administration, H2 2012 25
Assessment by Stage and Molecule Type, H2 2012 27
Friedreich Ataxia Therapeutics ' Drug Profile Updates 41
Friedreich Ataxia Therapeutics ' Discontinued Products 44
Friedreich Ataxia Therapeutics ' Dormant Products 45

List of Figures

Number of Products under Development for Friedreich Ataxia, H2 2012 8
Products under Development for Friedreich Ataxia ' Comparative Analysis, H2 2012 9
Products under Development by Companies, H2 2012 10
Products under Investigation by Universities/Institutes, H2 2012 11
Late Stage Products, H2 2012 12
Mid Clinical Stage Products, H2 2012 13
Early Clinical Stage Products, H2 2012 14
Pre-Clinical Stage Products, H2 2012 15
Assessment by Monotherapy Products, H2 2012 23
Assessment by Route of Administration, H2 2012 24
Assessment by Stage and Route of Administration, H2 2012 25
Assessment by Molecule Type, H2 2012 26
Assessment by Stage and Molecule Type, H2 2012 27


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